81 FR 67149 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 190 (September 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 190 (September 30, 2016)
| Page Range | 67149-67153 | |
| FR Document | 2016-23230 |
[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)] [Rules and Regulations] [Pages 67149-67153] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23230] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, and 558 [Docket No. FDA-2016-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address. [[Page 67150]] DATES: This rule is effective September 30, 2016. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July and August 2016, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm. Table 1--Original and Supplemental NADAs and ANADAs Approved During July and August 2016 -------------------------------------------------------------------------------------------------------------------------------------------------------- Effect of the Approval date File No. Sponsor Product name Species action/indications Public documents for use -------------------------------------------------------------------------------------------------------------------------------------------------------- July 24, 2016.................. 141-458 Merial, Inc., 3239 EQUIOXX Horses................. Original approval FOI Summary. Satellite Blvd., (firocoxib) for the control bldg. 500, Tablets. of pain and Duluth, GA 30096- inflammation 4640. associated with osteoarthritis in horses. July 20, 2016.................. 141-459 Intervet, Inc., 2 BRAVECTO Dogs, cats............. Original approval FOI Summary. Giralda Farms, (fluralaner for killing adult Madison, NJ 07940. topical solution) fleas, for the for Dogs. treatment and BRAVECTO prevention of (fluralaner flea topical solution) infestations, and for Cats. for the treatment and control of tick infestations in dogs and cats. August 12, 2016................ 141-461 Aratana NOCITA Dogs................... Original approval FOI Summary. Therapeutics, (bupivacaine to provide local Inc., 11400 liposome postoperative Tomahawk Creek injectable analgesia for Pkwy., Leawood, suspension). cranial cruciate KS 66211. ligament surgery in dogs. July 1, 2016................... 200-501 Cross Vetpharm Praziquantel Dogs................... Original approval FOI Summary. Group Ltd. (praziquantel) of a generic copy Broomhill Rd., Injection. of NADA 111-607. Tallaght, Dublin 24, Ireland. August 5, 2016................. 200-508 Cross Vetpharm BILOVET (tylosin) Cattle, swine.......... Original approval FOI Summary. Group Ltd. Injection. of a generic copy Broomhill Rd., of NADA 012-965. Tallaght, Dublin 24, Ireland. -------------------------------------------------------------------------------------------------------------------------------------------------------- II. Change of Sponsor's Address Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., Madison, WI 53719 has informed FDA that it has changed its address to P.O. Box 259158, Madison, WI 53725. Accordingly, the regulations at 21 CFR 510.600(c) will be amended to reflect this sponsor's change of address. III. Technical Amendments FDA has noticed that drug labeler codes (DLCs) in several sections of part 558 (21 CFR part 558) do not accurately reflect the sponsorship of a new animal drug application. At this time, we are amending part 558 to remove these DLCs. Also, FDA is amending the regulations to revise a human food safety warning for tulathromycin injectable solution in 21 CFR 522.2630 and to correct a cross-reference for combination medicated feeds in Sec. 558.128 (21 CFR 558.128). These actions are being taken to improve the accuracy of the regulations. The restrictions for veterinary feed directive (VFD) drugs in part 558 are being revised to reflect a uniform text. In addition, we are revising Sec. 558.59 to reflect a current format. These actions are being taken to improve the clarity of the regulations. This rule does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Parts 520, 522, 524, and 529 Animal drugs. 21 CFR Part 558 Animal drugs, Animal feeds. [[Page 67151]] Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 520, 522, 524, 529, and 558 are amended as follows: PART 510--NEW ANIMAL DRUGS 0 1. The authority citation for part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. Sec. 510.600 [Amended] 0 2. Revise Sec. 510.600 as follows: 0 a. In the table in paragraph (c)(1): 0 i. In the entries for ``Cronus Pharma LLC'', ``HQ Specialty Pharma Corp.'', ``OXIS International, Inc.'', ``Pharmgate LLC ``, ``Putney, Inc.'', ``SmartVet USA, Inc.'', and ``Wildlife Laboratories, Inc.'', remove ``Suite'' and in its place add ``suite''; 0 ii. In the entry for ``Merial, Inc.'', remove ``Bldg.'' and in its place add ``bldg.''; 0 iii. In the entry for ``Nexcyon Pharmaceuticals, Inc.'', remove ``644 West Washington Ave., Madison, WI 53719'' and in its place add ``P.O. Box 259158, Madison, WI 53725''; 0 b. In the table in paragraph (c)(2): 0 i. In the entries for ``024991'', ``026637'', ``042791'', ``053923'', ``069043'', ``069254'', and ``086001'', remove ``Suite'' and in its place add ``suite''; 0 ii. In the entry for ``050604'', remove ``Bldg.'' and in its place add ``bldg.''; and 0 iii. In the entry for ``050929'', remove ``644 West Washington Ave., Madison, WI 53719'' and in its place add ``P.O. Box 259158, Madison, WI 53725''. PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b 0 4. In Sec. 520.928, revise paragraph (c) to read as follows: Sec. 520.928 Firocoxib tablets. * * * * * (c) Conditions of use--(1) Dogs--(i) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily for osteoarthritis. Administer approximately 2 hours before soft tissue or orthopedic surgery. (ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis; and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses--(i) Amount. Administer one 57-mg tablet to horses weighing 800 to 1,300 lb once daily for up to 14 days. (ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 520.2345c [Amended] 0 5. In Sec. 520.2345c, remove paragraph (d)(1)(iii). PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 6. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 7. Add Sec. 522.224 to read as follows: Sec. 522.224 Bupivacaine. (a) Specifications. Each milliliter (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine. (b) Sponsor. See No. 086026 in Sec. 510.600(c) of this chapter. (c) Conditions of use in dogs--(1) Amount. Administer 5.3 mg/kg (0.4 mL/kg) by infiltration injection into the tissue layers at the time of incisional closure. (2) Indications for use. For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 8. In Sec. 522.1870, revise paragraphs (a), (c)(1)(i) and (iii), and (c)(2)(i) and (iii) to read as follows: Sec. 522.1870 Praziquantel. (a) Specifications. Each milliliter (mL) of solution contains 56.8 milligrams of praziquantel. * * * * * (c) * * * (1) * * * (i) Amount. Administer by subcutaneous or intramuscular injection for dogs and puppies 5 pounds (lb) and under, 0.3 mL; for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 mL/5 lb body weight to a maximum of 3 mL. * * * * * (iii) Limitations. Federal law restricts the drug to use by or on the order of a licensed veterinarian. (2) * * * (i) Amount. Administer by subcutaneous or intramuscular injection for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 11 lb and over, 0.6 mL maximum. * * * * * (iii) Limitations. Federal law restricts the drug to use by or on the order of a licensed veterinarian. 0 9. In Sec. 522.2630, revise paragraph (d)(1)(iii)(A) to read as follows: Sec. 522.2630 Tulathromycin. * * * * * (d) * * * (1) * * * (iii) * * * (A) Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * 0 10. Revise Sec. 522.2640 to read as follows: Sec. 522.2640 Tylosin. (a) Specifications. Each milliliter (mL) of solution contains 50 or 200 milligrams (mg) of tylosin activity (as tylosin base). (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter as follows: (1) No. 000986 for use of 50- or 200-mg/mL solutions as in paragraph (e) of this section. (2) Nos. 000010 and 061623 for use of a 200-mg/mL solution as in paragraphs (e)(1) and (2) of this section. (c) Related tolerances. See Sec. 556.740 of this chapter. (d) Special considerations. Labeling must bear the warning statements: ``Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.'' (e) Conditions of use--(1) Beef cattle and nonlactating dairy cattle--(i) Amount. Administer 8 mg per pound (mg/lb) of body weight by intramuscular injection once daily for not more than 5 consecutive days. Continue treatment 24 hours after symptoms disappear. (ii) Indications for use. Treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by A. pyogenes. [[Page 67152]] (iii) Limitations. Do not inject more than 10 mL per site. Use a 50-mg/mL solution for calves weighing less than 200 pounds. Cattle intended for human consumption must not be slaughtered within 21 days of the last use of this drug product. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. This product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in preruminating calves. (2) Swine--(i) Amount. Administer 4 mg/lb of body weight by intramuscular injection twice daily for not more than 3 consecutive days. Continue treatment 24 hours after symptoms disappear. If tylosin medicated drinking water is used as a followup treatment for swine dysentery, the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues. (ii) Indications for use. Treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed. (iii) Limitations. Do not inject more than 5 mL per site. Adverse reactions, including shock and death may result from overdosage in baby pigs. It is recommended that tylosin 50-mg/mL injection be used in pigs weighing less than 25 lbs. Swine intended for human consumption must not be slaughtered within 14 days of the last use of this drug product. (3) Dogs and cats--(i) Amount. Administer 3 to 5 mg/lb of body weight by intramuscular injection at 12- to 24-hour intervals. (ii) Indications for use--(A) Dogs. Treatment of upper respiratory infections such as bronchitis, tracheobronchitis, tracheitis, laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp., hemolytic Streptococci spp., and Pasteurella multocida. (B) Cats. Treatment of upper respiratory infections when caused by Staphylococci spp. and hemolytic Streptococci spp. and for feline pneumonitis when caused by tylosin-susceptible organisms. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 11. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 12. Add Sec. 524.998 to read as follows: Sec. 524.998 Fluralaner. (a) Specifications. Each milliliter of solution contains 280 milligrams (mg) fluralaner. (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Dogs--(i) Amount. Administer topically as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks. (ii) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black- legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater; for the treatment and control of A. americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 0 13. The authority citation for part 529 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 529.400 [Amended] 0 14. In Sec. 529.400, in paragraph (a), remove footnote 1. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 15. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. Sec. 558.58 [Amended] 0 16. In Sec. 558.58, in paragraph (e)(6), remove ``3.6'' and in its place add ``36.6''. 0 17. Revise Sec. 558.59 to read as follows: Sec. 558.59 Apramycin. (a) Specifications. Each pound of Type A article contains 75 grams apramycin (as apramycin sulfate). (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. (c) [Reserved] (d) Related tolerances. See Sec. 556.52 of this chapter. (e) Conditions of use in swine--(1) Amount. Feed at 150 grams apramycin per ton of Type C medicated feed as the sole ration for 14 consecutive days. (2) Indications for use. For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli. (3) Limitations. Withdraw 28 days before slaughter. Sec. 558.68 [Amended] 0 18. In Sec. 558.68, redesignate paragraphs (c) and (d) as paragraphs (d) and (c); and in paragraphs (e)(1)(i) and (e)(2)(i), remove ``000986'' and in its place add ``058198''. Sec. 558.128 [Amended] 0 19. In Sec. 558.128, in paragraph (e)(7)(xi), remove ``Sec. 558.600'' and in its place add ''Sec. 558.612''. Sec. 558.195 [Amended] 0 20. In Sec. 558.195, in paragraph (e)(1)(vi), remove ``000009'' and in its place add ``054771''; and in paragraphs (e)(2)(iii) and (v), remove ``000986'' wherever it appears and in its place add ``058198''. Sec. 558.261 [Amended] 0 21. In Sec. 558.261, redesignate paragraphs (c) and (d) as paragraphs (d) and (c). Sec. 558.295 [Amended] 0 22. In Sec. 558.295, remove and reserve paragraph (b). 0 23. In Sec. 558.325, revise paragraph (d)(3) to read as follows: Sec. 558.325 Lincomycin. * * * * * (d) * * * (3) Labeling of Type A medicated articles and single-ingredient Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following caution statement: ``The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined. Not for use in swine intended for breeding when lincomycin is fed at 20 grams per ton of complete feed.'' * * * * * Sec. 558.342 [Amended] 0 24. In Sec. 558.342, in paragraphs (e)(1)(iv),(ix), (x), and (xi), remove [[Page 67153]] ``000986'' wherever it appears and in its place add ``058198''. Sec. 558.366 [Amended] 0 25. In Sec. 558.366, in paragraph (d), in the entry for ``113.5 (0.0125 pct)'', remove ``000986'' and in its place add ``058198''. Sec. 558.618 [Amended] 0 26. In Sec. 558.618, redesignate paragraphs (c) and (d) as paragraphs (d) and (c). 0 27. In Sec. 558.633, revise paragraph (d)(1) to read as follows: Sec. 558.633 Tylvalocin. * * * * * (d) * * * (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements. * * * * * Dated: September 21, 2016. Tracey Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016-23230 Filed 9-29-16; 8:45 am] BILLING CODE 4164-01-P
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a petition is classified, as identified by (i) Petitions for duty suspensions and (b) Exceptions. (1) In calculating the
documentation supplied to the reductions that the Commission has estimated revenue loss required under
Commission and any supporting determined do not contain the the Act, the Commission may base its
information obtained by the information required under section estimates in whole or in part on the
Commission. 3(b)(2) of the Act. estimated values of imports submitted
(2) A determination of whether or not (ii) Petitions for duty suspensions and by petitioners in their petitions.
domestic production of the article that reductions with respect to which the (2) The Commission may disclose
is the subject of the petition exists, Commission has determined the some or all of the confidential business
taking into account the report of the petitioner is not a likely beneficiary. information provided to the
Secretary of Commerce under section (6) A list of petitions for duty Commission in petitions and public
3(c)(1) of the Act, and, if such suspensions and reductions that the comments to the U.S. Department of
production exists, whether or not a Commission does not recommend for Commerce for use in preparing its report
domestic producer of the article objects inclusion in a miscellaneous tariff bill, to the Commission and the Committees,
to the duty suspension or reduction. other than petitions specified in section and to the U.S. Department of
(3) Any technical changes to the 3(b)(3)(C)(ii)(V) of the Act. Agriculture and CBP for use in
description of the article that is the (c) The Commission will forward to providing information for Commerce’s
subject of the petition for the duty the Committees any additional report.
suspension or reduction that are information submitted to the § 220.14 Application of other Commission
necessary for purposes of administration Commission by the Secretary of rules.
when the article is presented for Commerce after the Commission
Commission rules applicable to the
importation, taking into account the transmits its preliminary report.
initiation and conduct of investigations,
report of the Secretary of Commerce
§ 220.12 Commission final report. including rules set out in subpart B of
under section 3(c)(2) of the Act.
(4) An estimate of the amount of loss (a) The Commission will submit its part 201 of this chapter (except § 201.9
in revenue to the United States that final report on each petition for a duty (methods employed in obtaining
would no longer be collected if the duty suspension or reduction specified in the information), § 201.14(a) (computation
preliminary report to the Committees of time), and § 201.15 (attorneys or
suspension or reduction takes effect.
(5) A determination of whether or not not later than 60 days after the agents)), shall not apply to Commission
the duty suspension or reduction is Commission submits its preliminary proceedings under this part.
available to any person that imports the report. The final report will contain the By order of the Commission.
article that is the subject of the duty following information— Issued: September 21, 2016.
suspension or reduction. (1) The information required to be Lisa R. Barton,
(6) The likely beneficiaries of each included in a preliminary report under Secretary to the Commission.
duty suspension or reduction, including section 3(b)(3)(C)(i)–(ii) of the Act and [FR Doc. 2016–23229 Filed 9–29–16; 8:45 am]
whether the petitioner is a likely updated as appropriate after considering BILLING CODE 7020–02–P
beneficiary. any information submitted by the
(b) The preliminary report will also Committees under section 3(b)(3)(D) of
include the following information: the Act.
(1) A list of petitions for duty DEPARTMENT OF HEALTH AND
(2) A determination of the HUMAN SERVICES
suspensions and reductions that meet Commission whether—
the requirements of the Act without (i) The duty suspension or reduction Food and Drug Administration
modifications. can likely be administered by U.S.
(2) A list of petitions for duty Customs and Border Protection; 21 CFR Parts 510, 520, 522, 524, 529,
suspensions and reductions for which (ii) The estimated loss in revenue to and 558
the Commission recommends technical the United States from the duty
corrections (i.e., corrections to the suspension or reduction does not [Docket No. FDA–2016–N–0002]
article description that do not otherwise exceed $500,000 in a calendar year
substantially alter the scope or HTS New Animal Drugs; Approval of New
during which the duty suspension or Animal Drug Applications; Change of
classification of the articles covered by reduction would be in effect; and
the petition) in order to meet the Sponsor’s Address
(iii) The duty suspension or reduction
requirements of the Act, with the is available to any person importing the AGENCY: Food and Drug Administration,
correction specified. articles that is the subject of the duty HHS.
(3) A list of petitions for duty suspension or reduction. Final rule; technical
ACTION:
suspensions and reductions for which (b) [Reserved] amendment.
the Commission recommends
modifications to the amount of the duty § 220.13 Confidential business SUMMARY: The Food and Drug
suspension or reduction that is the information. Administration (FDA, we) is amending
subject of the petition to comply with (a) In general. The Commission will the animal drug regulations to reflect
the requirements of the Act, with the not release information which the application-related actions for new
modification specified. Commission considers to be animal drug applications (NADAs) and
(4) A list of petitions for duty confidential business information abbreviated new animal drug
asabaliauskas on DSK3SPTVN1PROD with RULES
suspensions and reductions for which within the meaning of § 201.6(a) of this applications (ANADAs) during July and
the Commission recommends chapter unless the party submitting the August 2016. FDA is also informing the
modifications to the scope of the articles confidential business information had public of the availability of summaries
that are the subject of the petitions in notice, at the time of submission, that of the basis of approval and of
order to address objections by domestic such information would be released by environmental review documents,
producers to such petitions, with the the Commission, or such party where applicable. The animal drug
modifications specified. subsequently consents to the release of regulations are also being amended to
(5) A list of the following: the information. reflect a change of a sponsor’s address.
VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 E:\FR\FM\30SER1.SGM 30SER1](https://thefederalregister.org/doc/81_FR_67339/page/1.svg)
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Therefore, under the Federal Food, (iii) Limitations. Federal law restricts (2) * * *
Drug, and Cosmetic Act and under this drug to use by or on the order of (i) Amount. Administer by
authority delegated to the Commissioner a licensed veterinarian. subcutaneous or intramuscular injection
of Food and Drugs and redelegated to (2) Horses—(i) Amount. Administer for cats and kittens under 5 lb, 0.2 mL;
the Center for Veterinary Medicine, 21 one 57-mg tablet to horses weighing 800 5 to 10 lb, 0.4 mL; 11 lb and over, 0.6
CFR parts 510, 520, 522, 524, 529, and to 1,300 lb once daily for up to 14 days. mL maximum.
558 are amended as follows: (ii) Indications for use. For the control * * * * *
of pain and inflammation associated (iii) Limitations. Federal law restricts
PART 510—NEW ANIMAL DRUGS with osteoarthritis. the drug to use by or on the order of a
(iii) Limitations. Do not use in horses licensed veterinarian.
■ 1. The authority citation for part 510 intended for human consumption. ■ 9. In § 522.2630, revise paragraph
continues to read as follows: Federal law restricts this drug to use by (d)(1)(iii)(A) to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, or on the order of a licensed
353, 360b, 371, 379e. veterinarian. § 522.2630 Tulathromycin.
§ 510.600 [Amended] * * * * *
§ 520.2345c [Amended] (d) * * *
■ 2. Revise § 510.600 as follows: ■ 5. In § 520.2345c, remove paragraph (1) * * *
■ a. In the table in paragraph (c)(1): (d)(1)(iii). (iii) * * *
■ i. In the entries for ‘‘Cronus Pharma (A) Cattle intended for human
LLC’’, ‘‘HQ Specialty Pharma Corp.’’, PART 522—IMPLANTATION OR consumption must not be slaughtered
‘‘OXIS International, Inc.’’, ‘‘Pharmgate INJECTABLE DOSAGE FORM NEW within 18 days from the last treatment.
LLC ‘‘, ‘‘Putney, Inc.’’, ‘‘SmartVet USA, ANIMAL DRUGS This drug is not approved for use in
Inc.’’, and ‘‘Wildlife Laboratories, Inc.’’, female dairy cattle 20 months of age or
remove ‘‘Suite’’ and in its place add ■ 6. The authority citation for part 522
older, including dry dairy cows. Use in
‘‘suite’’; continues to read as follows:
these cattle may cause drug residues in
■ ii. In the entry for ‘‘Merial, Inc.’’, Authority: 21 U.S.C. 360b. milk and/or in calves born to these
remove ‘‘Bldg.’’ and in its place add
■ 7. Add § 522.224 to read as follows: cows. Federal law restricts this drug to
‘‘bldg.’’;
■ iii. In the entry for ‘‘Nexcyon
use by or on the order of a licensed
§ 522.224 Bupivacaine.
Pharmaceuticals, Inc.’’, remove ‘‘644 veterinarian.
(a) Specifications. Each milliliter (mL)
West Washington Ave., Madison, WI * * * * *
of liposomal suspension contains 13.3 ■ 10. Revise § 522.2640 to read as
53719’’ and in its place add ‘‘P.O. Box milligrams (mg) bupivacaine.
259158, Madison, WI 53725’’; follows:
(b) Sponsor. See No. 086026 in
■ b. In the table in paragraph (c)(2):
§ 510.600(c) of this chapter. § 522.2640 Tylosin.
■ i. In the entries for ‘‘024991’’,
(c) Conditions of use in dogs—(1) (a) Specifications. Each milliliter (mL)
‘‘026637’’, ‘‘042791’’, ‘‘053923’’, Amount. Administer 5.3 mg/kg (0.4 mL/
‘‘069043’’, ‘‘069254’’, and ‘‘086001’’, of solution contains 50 or 200
kg) by infiltration injection into the milligrams (mg) of tylosin activity (as
remove ‘‘Suite’’ and in its place add
tissue layers at the time of incisional tylosin base).
‘‘suite’’;
closure. (b) Sponsors. See sponsors in
■ ii. In the entry for ‘‘050604’’, remove
(2) Indications for use. For single-dose § 510.600(c) of this chapter as follows:
‘‘Bldg.’’ and in its place add ‘‘bldg.’’;
infiltration into the surgical site to (1) No. 000986 for use of 50- or 200-
and
■ iii. In the entry for ‘‘050929’’, remove
provide local postoperative analgesia for mg/mL solutions as in paragraph (e) of
‘‘644 West Washington Ave., Madison, cranial cruciate ligament surgery in this section.
WI 53719’’ and in its place add ‘‘P.O. dogs. (2) Nos. 000010 and 061623 for use of
(3) Limitations. Federal law restricts a 200-mg/mL solution as in paragraphs
Box 259158, Madison, WI 53725’’.
this drug to use by or on the order of (e)(1) and (2) of this section.
PART 520—ORAL DOSAGE FORM a licensed veterinarian. (c) Related tolerances. See § 556.740
NEW ANIMAL DRUGS ■ 8. In § 522.1870, revise paragraphs (a), of this chapter.
(c)(1)(i) and (iii), and (c)(2)(i) and (iii) to (d) Special considerations. Labeling
■ 3. The authority citation for part 520 read as follows: must bear the warning statements: ‘‘Do
continues to read as follows: not administer to horses or other
§ 522.1870 Praziquantel.
Authority: 21 U.S.C. 360b equines. Injection of tylosin in equines
(a) Specifications. Each milliliter (mL) has been fatal.’’
■ 4. In § 520.928, revise paragraph (c) to of solution contains 56.8 milligrams of
read as follows: (e) Conditions of use—(1) Beef cattle
praziquantel. and nonlactating dairy cattle—(i)
§ 520.928 Firocoxib tablets. * * * * * Amount. Administer 8 mg per pound
* * * * * (c) * * * (mg/lb) of body weight by intramuscular
(c) Conditions of use—(1) Dogs—(i) (1) * * * injection once daily for not more than
Amount. 5 mg/kg (2.27 mg/lb) body (i) Amount. Administer by 5 consecutive days. Continue treatment
weight. Administer once daily for subcutaneous or intramuscular injection 24 hours after symptoms disappear.
osteoarthritis. Administer for dogs and puppies 5 pounds (lb) and (ii) Indications for use. Treatment of
asabaliauskas on DSK3SPTVN1PROD with RULES
approximately 2 hours before soft tissue under, 0.3 mL; for 6 to 10 lb, 0.5 mL; bovine respiratory complex (shipping
or orthopedic surgery. for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 fever, pneumonia) usually associated
(ii) Indications for use. For the control mL/5 lb body weight to a maximum of with Pasteurella multocida and
of pain and inflammation associated 3 mL. Arcanobacterium pyogenes; foot rot
with osteoarthritis; and for the control * * * * * (necrotic pododermatitis) and calf
of postoperative pain and inflammation (iii) Limitations. Federal law restricts diphtheria caused by Fusobacterium
associated with soft-tissue and the drug to use by or on the order of a necrophorum and metritis caused by A.
orthopedic surgery. licensed veterinarian. pyogenes.
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![67152 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations
(iii) Limitations. Do not inject more PART 524—OPHTHALMIC AND § 558.59 Apramycin.
than 10 mL per site. Use a 50-mg/mL TOPICAL DOSAGE FORM NEW (a) Specifications. Each pound of
solution for calves weighing less than ANIMAL DRUGS Type A article contains 75 grams
200 pounds. Cattle intended for human apramycin (as apramycin sulfate).
consumption must not be slaughtered ■ 11. The authority citation for part 524 (b) Sponsor. See No. 058198 in
within 21 days of the last use of this continues to read as follows: § 510.600(c) of this chapter.
drug product. This drug product is not (c) [Reserved]
Authority: 21 U.S.C. 360b.
approved for use in female dairy cattle (d) Related tolerances. See § 556.52 of
20 months of age or older, including dry ■ 12. Add § 524.998 to read as follows: this chapter.
dairy cows. Use in these cattle may (e) Conditions of use in swine—(1)
§ 524.998 Fluralaner.
cause drug residues in milk and/or in Amount. Feed at 150 grams apramycin
calves born to these cows. This product (a) Specifications. Each milliliter of per ton of Type C medicated feed as the
is not approved for use in calves solution contains 280 milligrams (mg) sole ration for 14 consecutive days.
intended to be processed for veal. A fluralaner. (2) Indications for use. For control of
(b) Sponsor. See No. 000061 in porcine colibacillosis (weanling pig
withdrawal period has not been
§ 510.600(c) of this chapter. scours) caused by susceptible strains of
established in preruminating calves.
(c) Conditions of use—(1) Dogs—(i) Escherichia coli.
(2) Swine—(i) Amount. Administer 4 (3) Limitations. Withdraw 28 days
mg/lb of body weight by intramuscular Amount. Administer topically as a
single dose every 12 weeks according to before slaughter.
injection twice daily for not more than
3 consecutive days. Continue treatment the label dosage schedule to provide a § 558.68 [Amended]
24 hours after symptoms disappear. If minimum dose of 11.4 mg/lb (25 mg/kg) ■ 18. In § 558.68, redesignate
tylosin medicated drinking water is body weight. May be administered every paragraphs (c) and (d) as paragraphs (d)
used as a followup treatment for swine 8 weeks in case of potential exposure to and (c); and in paragraphs (e)(1)(i) and
dysentery, the animal should thereafter Amblyomma americanum ticks. (e)(2)(i), remove ‘‘000986’’ and in its
receive feed containing 40 to 100 grams (ii) Indications for use. Kills adult place add ‘‘058198’’.
of tylosin per ton for 2 weeks to assure fleas; for the treatment and prevention
of flea infestations (Ctenocephalides § 558.128 [Amended]
depletion of tissue residues.
felis) and the treatment and control of ■ 19. In § 558.128, in paragraph
(ii) Indications for use. Treatment of (e)(7)(xi), remove ‘‘§ 558.600’’ and in its
swine arthritis caused by Mycoplasma tick infestations (Ixodes scapularis
(black-legged tick), Dermacentor place add ″§ 558.612″.
hyosynoviae; swine pneumonia caused
by Pasteurella spp.; swine erysipelas variabilis (American dog tick), and § 558.195 [Amended]
caused by Erysipelothrix rhusiopathiae; Rhipicephalus sanguineus (brown dog
tick)) for 12 weeks in dogs and puppies ■ 20. In § 558.195, in paragraph
swine dysentery associated with (e)(1)(vi), remove ‘‘000009’’ and in its
Treponema hyodysenteriae when 6 months of age and older, and weighing
place add ‘‘054771’’; and in paragraphs
followed by appropriate medication in 4.4 lb or greater; for the treatment and
(e)(2)(iii) and (v), remove ‘‘000986’’
the drinking water and/or feed. control of A. americanum (lone star
wherever it appears and in its place add
tick) infestations for 8 weeks in dogs
(iii) Limitations. Do not inject more ‘‘058198’’.
and puppies 6 months of age and older,
than 5 mL per site. Adverse reactions, and weighing 4.4 lb or greater. § 558.261 [Amended]
including shock and death may result
(iii) Limitations. Federal law restricts ■ 21. In § 558.261, redesignate
from overdosage in baby pigs. It is
this drug to use by or on the order of paragraphs (c) and (d) as paragraphs (d)
recommended that tylosin 50-mg/mL
a licensed veterinarian. and (c).
injection be used in pigs weighing less
than 25 lbs. Swine intended for human (2) [Reserved]
§ 558.295 [Amended]
consumption must not be slaughtered PART 529—CERTAIN OTHER DOSAGE ■ 22. In § 558.295, remove and reserve
within 14 days of the last use of this FORM NEW ANIMAL DRUGS paragraph (b).
drug product. ■ 23. In § 558.325, revise paragraph
(3) Dogs and cats—(i) Amount. ■ 13. The authority citation for part 529 (d)(3) to read as follows:
Administer 3 to 5 mg/lb of body weight continues to read as follows:
by intramuscular injection at 12- to 24- § 558.325 Lincomycin.
Authority: 21 U.S.C. 360b. * * * * *
hour intervals.
(d) * * *
(ii) Indications for use—(A) Dogs. § 529.400 [Amended]
(3) Labeling of Type A medicated
Treatment of upper respiratory ■ 14. In § 529.400, in paragraph (a), articles and single-ingredient Type B
infections such as bronchitis, remove footnote 1. and Type C medicated feeds containing
tracheobronchitis, tracheitis, laryngitis,
lincomycin intended for use in swine
tonsillitis, and pneumonia caused by PART 558—NEW ANIMAL DRUGS FOR shall bear the following caution
Staphylococci spp., hemolytic USE IN ANIMAL FEEDS statement: ‘‘The effects of lincomycin on
Streptococci spp., and Pasteurella
swine reproductive performance,
multocida. ■ 15. The authority citation for part 558
pregnancy, and lactation have not been
(B) Cats. Treatment of upper continues to read as follows:
determined. Not for use in swine
asabaliauskas on DSK3SPTVN1PROD with RULES
respiratory infections when caused by Authority: 21 U.S.C. 354, 360b, 360ccc, intended for breeding when lincomycin
Staphylococci spp. and hemolytic 360ccc–1, 371. is fed at 20 grams per ton of complete
Streptococci spp. and for feline feed.’’
§ 558.58 [Amended]
pneumonitis when caused by tylosin-
* * * * *
susceptible organisms. ■ 16. In § 558.58, in paragraph (e)(6),
(iii) Limitations. Federal law restricts remove ‘‘3.6’’ and in its place add § 558.342 [Amended]
this drug to use by or on the order of ‘‘36.6’’. ■ 24. In § 558.342, in paragraphs
a licensed veterinarian. ■ 17. Revise § 558.59 to read as follows: (e)(1)(iv),(ix), (x), and (xi), remove
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![Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations 67153
‘‘000986’’ wherever it appears and in its Electronic Submissions information you claim to be confidential
place add ‘‘058198’’. Submit electronic objections in the with a heading or cover note that states
following way: ‘‘THIS DOCUMENT CONTAINS
§ 558.366 [Amended] CONFIDENTIAL INFORMATION.’’ The
• Federal eRulemaking Portal: http://
■ 25. In § 558.366, in paragraph (d), in Agency will review this copy, including
www.regulations.gov. Follow the
the entry for ‘‘113.5 (0.0125 pct)’’, the claimed confidential information, in
instructions for submitting comments.
remove ‘‘000986’’ and in its place add its consideration of comments. The
Objections submitted electronically,
‘‘058198’’. second copy, which will have the
including attachments, to http://
§ 558.618 [Amended] www.regulations.gov will be posted to claimed confidential information
the docket unchanged. Because your redacted/blacked out, will be available
■ 26. In § 558.618, redesignate for public viewing and posted on http://
paragraphs (c) and (d) as paragraphs (d) objection will be made public, you are
solely responsible for ensuring that your www.regulations.gov. Submit both
and (c). copies to the Division of Dockets
■ 27. In § 558.633, revise paragraph objection does not include any
confidential information that you or a Management. If you do not wish your
(d)(1) to read as follows: name and contact information to be
third party may not wish to be posted,
§ 558.633 Tylvalocin. such as medical information, your or made publicly available, you can
anyone else’s Social Security number, or provide this information on the cover
* * * * *
confidential business information, such sheet and not in the body of your
(d) * * *
as a manufacturing process. Please note objections and you must identify this
(1) Federal law restricts medicated
that if you include your name, contact information as ‘‘confidential.’’ Any
feed containing this veterinary feed
information, or other information that information marked as ‘‘confidential’’
directive (VFD) drug to use by or on the
identifies you in the body of your will not be disclosed except in
order of a licensed veterinarian. See
objection, that information will be accordance with 21 CFR 10.20 and other
§ 558.6 for additional requirements.
posted on http://www.regulations.gov. applicable disclosure law. For more
* * * * * information about FDA’s posting of
• If you want to submit an objection
Dated: September 21, 2016. with confidential information that you comments to public dockets, see 80 FR
Tracey Forfa, do not wish to be made available to the 56469, September 18, 2015, or access
Deputy Director, Center for Veterinary public, submit the objection as a the information at: http://www.fda.gov/
Medicine. written/paper submission and in the regulatoryinformation/dockets/
[FR Doc. 2016–23230 Filed 9–29–16; 8:45 am] manner detailed (see ‘‘Written/Paper default.htm.
BILLING CODE 4164–01–P Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
read background documents or the
Written/Paper Submissions electronic and written/paper objections
DEPARTMENT OF HEALTH AND Submit written/paper submissions as received, go to http://
HUMAN SERVICES follows: www.regulations.gov and insert the
• Mail/Hand delivery/Courier (for docket number, found in brackets in the
Food and Drug Administration written/paper submissions): Division of heading of this document, into the
Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
21 CFR Part 573 and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
[Docket No. FDA–2014–F–0988] • For written/paper objections 1061, Rockville, MD 20852.
submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
Food Additives Permitted in Feed and Management, FDA will post your Chelsea Trull, Center for Veterinary
Drinking Water of Animals; Feed Grade objection, as well as any attachments, Medicine, Food and Drug
Sodium Formate except for information submitted, Administration, 7519 Standish Pl.,
marked and identified, as confidential, Rockville, MD 20855, 240–402–6729,
AGENCY: Food and Drug Administration,
if submitted as detailed in chelsea.trull@fda.hhs.gov.
HHS.
‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
ACTION: Final rule. Instructions: All submissions received
must include the Docket No. FDA– I. Background
SUMMARY: The Food and Drug
Administration (FDA, we, the Agency) 2014–F–0988 for ‘‘Food Additives In a document published in the
is amending the regulations for food Permitted in Feed and Drinking Water Federal Register of July 25, 2014 (79 FR
additives permitted in feed and drinking of Animals; Feed Grade Sodium 43325), FDA announced that we had
water of animals to provide for the safe Formate.’’ Received objections will be filed a food additive petition (animal
use of feed grade sodium formate as a placed in the docket and, except for use) (FAP 2286) submitted by BASF
feed acidifying agent in complete swine those submitted as ‘‘Confidential Corp., 100 Park Ave., Florham Park, NJ
feeds. This action is in response to a Submissions,’’ publicly viewable at 07932. The petition proposed that the
food additive petition filed by BASF http://www.regulations.gov or at the regulations for food additives permitted
Corp. Division of Dockets Management in feed and drinking water of animals be
between 9 a.m. and 4 p.m., Monday amended to provide for the safe use of
asabaliauskas on DSK3SPTVN1PROD with RULES
DATES: This rule is effective September through Friday. feed grade sodium formate as a feed
30, 2016. Submit either electronic or • Confidential Submissions—To acidifying agent in complete swine
written objections and requests for a submit an objection with confidential feeds. The notice of petition provided
hearing by October 31, 2016. See section information that you do not wish to be for a 30-day comment period on the
V of this document for further made publicly available, submit your petitioner’s request for categorical
information on the filing of objections. objections only as a written/paper exclusion from preparing an
ADDRESSES: You may submit objections submission. You should submit two environmental assessment or
and requests for a hearing as follows: copies total. One copy will include the environmental impact statement.
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Document Created: 2018-02-09 13:33:49
Document Modified: 2018-02-09 13:33:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; technical amendment. | |
| Dates | This rule is effective September 30, 2016. | |
| Contact | George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected] | |
| FR Citation | 81 FR 67149 | |
| CFR Citation | 21
CFR
510 21 CFR 520 21 CFR 522 21 CFR 524 21 CFR 529 21 CFR 558 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Animal Feeds |
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